FDA recall D-0963-2016

Novacare, LLC · Class I · drug

Product

Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-08-24
Report date
2016-06-15
Termination date
2017-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0963-2016